Director, Technical Operations, EXM US

Job Description

Technical Operations Director, Drug Substance EXM

An exciting opportunity has arisen for a Director of Technical Operations, EXM Drug substance (DS), to provide strategic and hands-on technical leadership across our expanding biologics external manufacturing network in the US.

Reporting to the Head of Biologics Technical Operations DS, this role will set the standard for technical excellence and receiving-unit excellence across technology transfer, commercialization, and sustained manufacturing performance.

This role requires a leader who can translate process science into reliable manufacturing performance, build strong technical capability within the organization, and create the conditions for predictable, compliant, and sustainable supply across a complex biologics portfolio.

The Director will provide end-to-end technical stewardship for receiving-unit activities, ensuring that process, equipment, and control strategy knowledge are effectively transferred and embedded at site level, and that operational readiness is established early and comprehensively.  The Director will drive  organizational capability by coaching and leading high-performing scientists and engineers, championing continuous improvement, and embedding a culture of technical excellence, accountability, and receiving-unit readiness.

Success in this position will require deep expertise in biologics drug substance manufacturing, technical operations, and technology transfer, coupled with a demonstrated ability to lead through complexity, influence across functions and partners, and build high-performing teams of scientists and engineers. The ideal candidate will bring strong experience in receiving-unit readiness, external manufacturing and CMO engagement, regulatory and quality systems, and the practical application of risk management to deliver robust processes and durable performance.

Responsibilities

Primary Responsibilities

Technical Ownership & Process Stewardship

• Drive expectations of deep technical understanding of the CMO partner’s manufacturing facilities and equipment at scale and in their MSAT labs, achieved by and not limited to on-site presence at the CMO.  Also drive expectations of deep process knowledge of the programs, scale down models and filings, and active engagement on-site with SU functions.

• Lead receiving unit New Product Introduction & Tech Transfer activities, ensuring deep understanding of the interconnectivity between operations and the science behind our products (e.g., end-to end risks, control strategy) to drive on-time and right-first time process and site introduction and to influence/guide development and characterization.

• Process equipment SMEs for the sites they are accountable for, connected to the network of other tech ops teams with similar equipment and/or processes.

• Provide on-site SME support during PPQ, early production and throughout commercial manufacture of our products; act as escalation point for multi‑site issues. 

• Support health authority interaction (queries and audits) that affect site activities, working with CMO and internal CMC organisations to provide the necessary support (audits, submissions)

• Actively support commercialization teams in representing facility & operational considerations during development

• Drive product life cycle management – developing and implementing process changes to ensure long term product robustness and compliance and driving productivity through day-to-day application of MPS. 

• Build strong partnerships across Manufacturing, Quality, Regulatory, Supply Chain, Process Development, and external partners to ensure effective knowledge transfer, aligned decision-making, and reliable execution across the network.

Investigations, RCA & Complex Problem Solving

• Serve as the technical authority for complex deviations, investigations, root cause analysis, change management, and inspection readiness, ensuring a high standard of scientific rigor, implementation of high quality, sustainable CAPAs  and operational discipline.

• Feed understanding and learnings from supply production into development teams and across Operations teams.

Risk Management, Monitoring & Preventive Action

• Establish and support Proactive Process Monitoring at CMOs pre-PPQ and throughout the product lifecycle of product, including cross-site monitoring.

• Detect trends at site & cross-site, as well as cross programs as appropriate, sustain and/or improve performance, including leadership of technical risk reviews to drive timely mitigations and

• Own stewardship of product/process and unit‑operation knowledge